The primary objective of the Biostatistics Core is to assist to the project investigators in the design, conduct, and analysis ofthe laboratory and clinical studies proposed in this program project grant (PPG). This core is led by Dr. Gary Rosner, Director of the Oncology Biostatistics and Bioinformatics Division. The Core focuses its efforts on assisting both the clinical and laboratory investigators in translating their pre-clinical studies into clinical studies by providing state-of-the-art experimental designs and analyses through statistical consultation and collaboration with respect to methodology, feasibility, safety monitoring, analysis, and reporting of clinical and laboratory studies. Additionally, Core members work closely with members of the Research Information Technology Systems (RITS) group, part of Oncology's Division of Biostatistics and Bioinformatics, to provide quality-controlled data in a systematic, efficient, and coordinated fashion so that accurate, complete, validated databases are available. This core has been and continues to be an integral part of the research accomplishments of the individual projects of this program project application